A Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps (MERT)
This study is currently recruiting participants.
Verified November 2012 by Birmingham Women's NHS Foundation Trust
Sponsor:
Birmingham Women's NHS Foundation Trust
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01509313
First received: January 5, 2012
Last updated: November 7, 2012
Last verified: November 2012
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Purpose
Outpatient polyp treatment can be performed in a few different ways but generally involves passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through which specifically designed miniature operating instruments are passed to remove the polyp(s). At present the most commonly used instruments use an electrical cutting edge. However, a new instrument using a mechanical cutting edge has come to market. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting. Therefore, the investigators want to compare the electrical and mechanical instruments for speed, completeness of polyp removal and patient acceptability.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Polyps |
Device: hysteroscopic morcellator (TruClear) Device: Bipolar Electrical resectoscope (Versapoint) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps |
Further study details as provided by Birmingham Women's NHS Foundation Trust:
Primary Outcome Measures:
- The time taken for polyp removal [ Time Frame: at the time of surgery (day 1 intraoperatively) ] [ Designated as safety issue: No ]The time taken to remove the polyp will be defined as the time from insertion to removal of vaginal instrumentation post-randomisation
Secondary Outcome Measures:
- Patient acceptability or pain [ Time Frame: immediately after the surgery (day 1) ] [ Designated as safety issue: No ]The acceptability of the trial will be assessed a questionnaire using pain visual analogue scores. The patient will be given a preoperative questionnarie to get a pain baseline and this will be followed postoperative pain questionnaire.
- Completion of polyp removal [ Time Frame: at the time of surgery (day 1 intraoperatively) ] [ Designated as safety issue: No ]A complete uterine polypectomy will be defined as the detachment and retrieval of all visible polyp tissue (single or multiple polyps), such that no polyp remnants remain within the uterine cavity. An incomplete procedure will include any of the following: (i) failure to detach any polyp tissue from the uterine wall; (ii) partial detachment of polyp(s) from the uterine wall and (iii) failure to retrieve the detached specimen from the uterine cavity
| Estimated Enrollment: | 110 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Uterine polypectomy using morcellator
A new instrument using a mechanical cutting edge has come to market for uterine polypectomy. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker than current techniques. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting.
|
Device: hysteroscopic morcellator (TruClear)
It can be used to treat uterine pathology with a mechanical cutting edge
Other Name: TruClear(Smith&Nephew, USA)
|
|
Active Comparator: Electical Resection
At present the most commonly used device for removing the uterine polyps in the outpatient setting is by electrical resection. This will provide comparison for the morcellator device being tested
|
Device: Bipolar Electrical resectoscope (Versapoint)
It can be used to treat uterine pathology with an electrical cutting edge
Other Name: Versapoint® (Gynecare; Ethicon Inc., New Jersey, USA).
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Finding of a benign polyp on diagnostic hysteroscopy
- Patient considered able to tolerate outpatient hysteroscopic polypectomy based upon the response to preliminary diagnostic hysteroscopy. NB. all polyps diagnosed at hysteroscopy will be considered feasible to remove in the outpatient setting regardless of size, location or number. Patient factor(s) will be the only exclusion criteria following the diagnosis of benign, uterine polyp(s).
- Need for polypectomy
- Written informed consent
Exclusion Criteria:
• Hysteroscopic features suggesting malignant lesion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509313
Contacts
| Contact: Thomas J Clark, MBChB MD | 01216074712 | justin.clark@bwhct.nhs.uk |
| Contact: Paul P Smith, MBChB BSci | 01216272702 | paul.smith@bwhct.nhs.uk |
Locations
| United Kingdom | |
| Birmingham Womens Hospital | Recruiting |
| Birmingham, West Midlands, United Kingdom, B15 2TG | |
| Contact: Thomas J Clark, MBChB MD 00441216074712 justin.clark@bwhct.nhs.uk | |
| Contact: Paul P Smith, MBChB BSci 00441216272702 paul.smith@bwhct.nhs.uk | |
| Sub-Investigator: Paul P Smith, MBChB | |
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
Smith & Nephew, Inc.
Investigators
| Principal Investigator: | Thomas J Clark, MBChB | Birmingham Womens Hospital |
More Information
No publications provided
| Responsible Party: | Thomas Justin Clark, Consultant Obstetrics and Gynaecologist, Birmingham Women's NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01509313 History of Changes |
| Other Study ID Numbers: | PPS-MERT-01 |
| Study First Received: | January 5, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by Birmingham Women's NHS Foundation Trust:
|
endometrial polyps uterine polyps morcellator hysteroscopy |
Additional relevant MeSH terms:
|
Polyps Adenoma Uterine Neoplasms Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013